Director, Biologics Analytics & GMP Operations

MSD; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Job summary

MSD in Rahway, NJ is seeking a Director to lead a growing GMP analytical team supporting biologics manufacturing. You will drive development of people, lab capability, and a culture of quality and compliance during rapid expansion into sterile drug-product filling and ADCs.

Responsibilities include overseeing batch-release, stability testing, method validation, and cross-functional partnerships with Manufacturing, Quality, and Regulatory to align testing priorities and scale operations.

Qualifications

• Ph.D. in analytical chemistry, biochemistry, biotechnology, pharmaceutical sciences, or a related discipline with 8+ years of pharmaceutical experience; or
• MS with 10+ years; or
• BS with 14+ years.

Responsibilities

• Lead and develop a growing team of scientists and people leaders responsible for GMP analytical testing and manufacturing support across multiple biologics operations.
• Build the organizational structure, workforce plan, technical expertise, and leadership capacity to support significant growth in portfolio demand and laboratory scope.
• Establish clear expectations and operating practices that allow growth while maintaining a culture of quality, scientific rigor, safety, data integrity, and accountability.
• Provide leadership for batch-release and stability testing, ensuring timely, reliable, and compliant delivery of analytical results for product disposition and supply.
• Oversee analytical support for manufacturing, including raw-material and in-process testing for standard monoclonal antibody production, ADC manufacturing, and sterile drug-product filling.
• Lead GMP Operations participation in early-stage analytical method validation and transition of methods from development into routine GMP use with Validation Strategy team.
• Provide laboratory input to validation plans and ensure readiness to execute studies and transition validated methods to routine use.
• Build analytical readiness for new manufacturing capabilities, including capacity, equipment, methods, materials, data systems, training, staffing, and expertise.
• Balance ongoing GMP operations with longer-term work to prepare for new facilities, technologies, and expanding portfolio.
• Maintain inspection readiness through documentation, disciplined practices, investigations, and CAPA.
• Proactively identify and manage quality and operational risks with increasing workload and new technologies.
• Provide technical leadership for analytical events, method-performance issues, and other risks affecting product quality or schedules.
• Partner with Manufacturing, Quality, analytical development, technical operations, and Regulatory teams to align testing priorities and risk mitigation.
• Establish performance measures and standardized ways of working to improve reliability, right-first-time execution, efficiency, and predictability.
• Develop scientific and leadership talent, strengthen succession plans, and foster an inclusive, high-performing organization.

Skills

Analytical Chemistry

Biologics

GMP

Leadership

Regulatory

Education

Ph.D. in analytical chemistry/biochemistry/biotechnology/pharmaceutical sciences

MS in a related field

BS in related field

Job description

MSD in Rahway, NJ is seeking a Director to lead a growing GMP analytical team supporting biologics manufacturing. You will drive development of people, lab capability, and a culture of quality and compliance during rapid expansion into sterile drug-product filling and ADCs.

Responsibilities include overseeing batch-release, stability testing, method validation, and cross-functional partnerships with Manufacturing, Quality, and Regulatory to align testing priorities and scale operations.